safety, tolerability, distribution & dose effect of neoadjuvant transarterial chemoembolization with doxorubicin in prostate cancer patients before radical prostatectomy

Conditions: Prostate Cancer

Summary: our hypothesis is that the doxorubicin eluting-beads currently used in hepato-oncology might be applicable to high-grade prostate cancer before radical prostatectomy. the primary objective of this phase iia pilot study is to evaluate the safety of performing prostate embolization with doxorubicin eluting-beads according to different loading doses. four dose levels will be tested: doxorubicin-free beads to test the effect of embolization alone, 2.5 mg of doxorubicin (1/20 of the dose administered for liver cancers), 5 mg and 10 mg of doxorubicin. the secondary objectives of the study are to evaluate the tolerance (functionnal questionaries at d0, d14 m1 and m3; collection of complications at d1, d5, d14, m1, m3; mri at d14), evaluate the systemic diffusion of doxorubicin (doxorubinemia at d1), evaluate an early anti-tumor effect of the treatment (via a prostate-specific antigen test at d14 m1, m3 and magnetic resonance imaging at d14), describe the distribution of beads observed on the surgical specimen and evaluate the dose effect at 1 month and 3 months after surgery (via a prostate-specific antigen test at d14, m1, m3 and magnetic resonance imaging at d14).


Eligibility criteria:
inclusion criteria: * patients must have given written informed consent. * patients must be affiliated to or benefit from a health insurance scheme. * patients with a high-risk prostate cancer with a gleason score of 9-10 on the biopsy, candidate for a multimodal treatment with radical prostatectomy validated at the multidisciplinary meeting. * patients with a normal blood count. * patients with a normal liver function test. * patients with an electrocardiogram including left ventricle ejection fraction (ventricular scintigraphy or echocardiography) and an echocardiogram allowing us to rule out heart disease. * patient must be completely recovered from acute toxicities (such as stomatitis, neutropenia, thrombopenia and generalized infections) caused by a previous cytotoxic treatment. * oms/ecog score≤1 (to guard against a possible loss of therapeutic opportunity related to a delay in surgery caused by chemo-embolization). exclusion criteria: * patients who are taking part in another study. * patients in an exclusion period determined by a previous study. * patients under legal guardianship, curatorship or tutorship. * patients not in condition to be able to express his consent (e.g. patient undergoing psychiatric treatment with mental disorders) * patients who refuse to sign the consent form. * patients for whom it is impossible to give clear information. • patient already has a metastatic disease. * patients who have contraindications for surgery. * patients with a rectal or vesicular collateral pathology that cannot be excluded or a collateral penile pathology which, by precaution, would not allow embolization (unknown effect on the erection in the event of arterial exclusion). * patients with a contraindication for magnetic resonance imaging (pacemaker incompatible with mri, claustrophobia, metal apparatus, total hip prosthesis). * patients with a past history of aortobifemoral bypass procedure or other vascular surgery making endovascular access to the prostate arteries impossible. * patients with irreversible hemostasis disorder: tp \ twice the control, platelets \< 60 g/l. * patients with contraindications as mentioned in the summary of product characteristics for doxorubicin.

Keywords: doxorubicin beads embolization chemoembolization prostate cancer